Docetaxel and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors

This study has been completed.
Sponsor:
Collaborators:
Genentech
Aventis Pharmaceuticals
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00390429
First received: October 18, 2006
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with erlotinib may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with docetaxel in treating patients with solid tumors and to see how well they work in treating patients with advanced non-small cell lung cancer. (Phase I portion of the study treating patients with any solid tumor was completed as of 12/01/2004)


Condition Intervention Phase
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: docetaxel
Drug: erlotinib hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Docetaxel and OSI-774 (Erlotinib) in Solid Tumor Patients With an Emphasis on NSCLC Using Molecular Correlates as Potential Markers of Response

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Safety and toxicity of erlotinib hydrochloride and docetaxel as measured by NCI CTC v3.0 on day 8 of course 1 and on day 1 of every subsequent course (Phase I [completed as of 12/01/2004]) [ Time Frame: 12/01/2004 ] [ Designated as safety issue: Yes ]
  • Response rate (Phase II) [ Time Frame: Completion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of toxicity of two different schedules of erlotinib hydrochloride and docetaxel (Phase I [completed as of 12/01/2004]) [ Time Frame: 12/01/2004 ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose of two different schedules of erlotinib hydrochloride and docetaxel (Phase I [completed as of 12/01/2004]) [ Time Frame: 12/01/2004 ] [ Designated as safety issue: Yes ]
  • Overall survival (Phase II) [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
  • Progression-free survival (Phase II) [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
  • Frequency and severity of toxicities (Phase II) [ Time Frame: Completion of study ] [ Designated as safety issue: Yes ]
  • Prognostic significance of epithelial growth factor receptor (EGFR) expression [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
  • Correlation of baseline EGFR levels with clinical outcome [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
  • Correlation of basal levels of p27 with response rate and overall survival [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
  • Correlation of phospho-EGFR with increased p27 and clinical outcome [ Time Frame: Completion of study ] [ Designated as safety issue: No ]
  • Correlation of EGFR polymorphisms with treatment response and clinical outcome [ Time Frame: Completion of study ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: July 2002
Study Completion Date: August 2012
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I, Group I (completed)
Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.
Drug: docetaxel
Given IV
Other Name: Taxotere
Drug: erlotinib hydrochloride
Given orally
Other Names:
  • OSI-774
  • Tarceva
Experimental: Phase I, Group II (completed)
Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression.
Drug: docetaxel
Given IV
Other Name: Taxotere
Drug: erlotinib hydrochloride
Given orally
Other Names:
  • OSI-774
  • Tarceva
Experimental: Phase II
Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity.
Drug: docetaxel
Given IV
Other Name: Taxotere
Drug: erlotinib hydrochloride
Given orally
Other Names:
  • OSI-774
  • Tarceva

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For the phase II portion patients must have cytologically or histologically proven NSCLC. (Completed 12/1/04 - For the phase I portion of the study patients must have cytologically or histologically proven advanced solid tumors for which there is no standard therapy of curative intent).
  • For the phase II portion patients must have disease that has progressed or recurred after treatment with platinum based therapy. Patients that have stable disease after front line platinum based therapy is also eligible.
  • No more than 1 previous treatment for metastatic disease is allowed for the phase II portion. (Completed 12/1/04 - Any number of prior chemotherapy regimens for metastatic disease are allowed for the phase I portion).
  • Patients must have measurable disease by RECIST criteria. Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy. (Completed 12/1/04 - Patients with evaluable disease may be included in the phase I portion of the trial.
  • Patients must be 18 years of age or older.
  • Patients must have a performance status of 0-1 for the phase II portion of the trial. (Completed 12/1/04 - performance status of 0-2 for is allowed for the phase I portion of study
  • Patients must have an estimated survival of at least 3 months.
  • Any prior chemotherapy that patients have received has to have been completed at least 4 weeks prior to start of OSI-774/Docetaxel. For prior mitomycin chemotherapy a 6-week interval is required. Prior radiation must have been completed at least 2 weeks prior to start of therapy. All side effects must have resolved prior to start of OSI-774/Docetaxel.
  • Patients must have adequate renal function as documented by a serum creatinine < 1.5 mg/dl or a calculated creatinine clearance of > 50 ml/min (see appendix for formula for calculating creatinine clearance).
  • Patients must have adequate liver function as documented by serum bilirubin < ULN. AST must be < 2.5 x institutional upper limit of normal.
  • Patients must have a pretreatment granulocyte count of >1500/mm3 and platelet count of >100 000/mm3.
  • Patients with asymptomatic treated brain metastasis (surgical resection or radiotherapy) may be included if they are neurologically stable and have been off steroids and anticonvulsants for at least 4 weeks. Because of the possibility of treatment related neurological toxicity it is difficult to evaluate for toxicity in the presence of symptomatic brain metastasis.
  • All patients must give written informed consent.
  • Able to take and retain oral medication.
  • Patients of reproductive potential must agree to use effective contraceptive method while on treatment and for 3 months afterwards as the effects of these drugs on the unborn fetus are unknown.
  • Patients on Coumadin should have their INR monitored at least once per week or more frequently depending on the investigators judgment. There have been some case reports of increased INR when Coumadin is co-administered with OSI-774/placebo.

Exclusion Criteria:

  • May not have previously received docetaxel; OSI-774 or any prior EGFR targeted therapy.
  • Females can not be pregnant or breastfeeding as the effects of these drugs on the unborn fetus are unknown. Documentation of a negative pregnancy test is required for all women of reproductive potential.
  • Patients with symptomatic brain metastasis or still requiring steroids may not be included.
  • Clinically significant ophthalmologic abnormalities will be excluded. This includes severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren's syndrome, severe exposure keratopathy, or other disorders that might increase the risk of corneal epithelial injury.
  • A history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  • Pre-existing neuropathy > grade 2 may not participate
  • No other prior malignancy is allowed for the phase II portion except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for over five years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390429

Locations
United States, California
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Genentech
Aventis Pharmaceuticals
Investigators
Study Chair: David R. Gandara, MD University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00390429     History of Changes
Other Study ID Numbers: CDR0000505821, P30CA093373, UCDCC-128, UCDCC-200311717-5, AVENTIS-Z1001055
Study First Received: October 18, 2006
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Davis:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2014